The following data is part of a premarket notification filed by Technomed Medical Systems, Sa with the FDA for Sonolith I-sys Lithotriper.
| Device ID | K083614 |
| 510k Number | K083614 |
| Device Name: | SONOLITH I-SYS LITHOTRIPER |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | TECHNOMED MEDICAL SYSTEMS, SA 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Contact | Lynette L Howard |
| Correspondent | Lynette L Howard TECHNOMED MEDICAL SYSTEMS, SA 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-07-27 |
| Summary: | summary |